MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer

Not Applicable

• Conditions: Magnetic Resonance-linac; Stereotactic Ablative RT; Adaptive Radiotherapy; Prostate Cancer; Radiotherapy Side Effect; Localised Disease; Oligometastatic Disease
• Interventions: Device: MR-linac

• Registration Number: NCT05183074
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

1. To investigate the tolerability of MR-linac based stereotactic ablative radiotherapy (MRL-SBRT)for patients with localized prostate cancer

2. To assess the acute and late toxicities, efficacy and quality of life for patients treated by MRL-SBRT

3. To simulate the dose planning and assess the feasibility of simultaneous-boost for MR-prominent foci

4. To investigate the relationship between the changes of blood and tissue biomarkers and manifestations on mp-MRI pre-/post-MRL-SBRT, to further ascertain the predictive factors of local persisting and/or relapse disease

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-20
• Last Update Submitted: 2021-12-20
• Study First Posted: 2022-01-10
• Last Update Posted: 2022-01-10
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Age≥18 years。
• Histology confirmed prostate cancer.
• Risk stratification, localised disease including patients with low-risk(cT1-T2a，PSA <10ng/mL，Gleason score≤6) who refuse active surveillance, favorable or unfavorable intermediate-risk and selected high-risk(cT2b-T3a or minimally T3b，PSA 10-40ng/mL，Gleason score 7-8) disease.
• Oligo-metastatic disease including patients with prostate in-situ and oligometastatic disease (no limit to mets number and organs, with all metastatic foci can be safely treated by radical SBRT dose)
• ECOG 0-2
• Postate gland volume ≤100cc
• IPSS score of <18
• Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed

Exclusion Criteria

• Contraindications to MRI.
• TURP within the past 6 months
• Ulcerative colitis, Crohn's Disease, ataxia telangiectasia, or systemic lupus erythematosus
• Previous pelvic irradiation
• Refuse contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MR-linac group	MR-linac	Pts received ultra-hypofractionated RT for primary w/o adjacent oligo-metastatic diseases on 1.5-Tesla MR-Linac

Primary Outcome Measures

Name	Time	Method
The Incidence of Acute GU and GI toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Three months post-MRL-SBRT	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
The Incidence of Late toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	6-months, 1-year and 2-year	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Quality of life evaluation	Every 2 weeks during SBRT and till 8 weeks after RT completion, every 3 months to 2 years and every 6 months to 5 years, and yearly thereafter	Evaluate quality of life of patients by QOL questionnaires at different time points
Biochemical-relapse free survival	2-year

Trial Locations

Locations (1)

Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China